Date Initiated by Firm |
February 04, 2009 |
Date Posted |
July 07, 2009 |
Recall Status1 |
Terminated 3 on August 20, 2009 |
Recall Number |
Z-1553-2009 |
Recall Event ID |
51951 |
510(K)Number |
K042384
|
Product Classification |
Electrode, depth - Product Code GZL
|
Product |
Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468. |
Code Information |
Lot Number: 4468-071408. |
Recalling Firm/ Manufacturer |
Cyberkinetics Neurotechnology Systems, Inc. 100 Foxboro Blvd Ste 240 Foxboro MA 02035-2800
|
For Additional Information Contact |
801-582-5533 Ext. 235
|
Manufacturer Reason for Recall |
Sterility of product cannot be assured
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Cyberkinetics Neurology Systems (CKI) notified the Distributor, Blackrock Microsystem, of the affected device. Blackrock notified the final user by email on February 4, 2009. |
Quantity in Commerce |
2 units |
Distribution |
Nationwide Distribution - State of MA. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GZL and Original Applicant = CYBERKINETICS, INC. (CKI)
|